Evaluation of adherence and tolerability of prolonged-release tacrolimus (Advagraf™) in kidney transplant patients in Germany: a multicenter, noninterventional study
This study assessed adherence to prolonged-release tacrolimus (PR-T)-based immunosuppression during routine maintenance of renal transplant recipients in Germany. Patients had received PR-T for ≥1 month at inclusion. Data were collected during four visits (V): baseline (V1), 6 (V2), 12 (V3), and 18...
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| Main Authors: | , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
2018
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| In: |
Clinical transplantation
Year: 2017, Volume: 32, Issue: 1 |
| ISSN: | 1399-0012 |
| DOI: | 10.1111/ctr.13142 |
| Online Access: | Verlag, Volltext: https://doi.org/10.1111/ctr.13142 Verlag, Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1111/ctr.13142 
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| Author Notes: | Lukas J. Lehner, Petra Reinke, Jan H. Hörstrup, Thomas Rath, Barbara Suwelack, Bernhard K. Krämer, Klemens Budde, Bernhard Banas |
| Summary: | This study assessed adherence to prolonged-release tacrolimus (PR-T)-based immunosuppression during routine maintenance of renal transplant recipients in Germany. Patients had received PR-T for ≥1 month at inclusion. Data were collected during four visits (V): baseline (V1), 6 (V2), 12 (V3), and 18 (V4) months. Composite primary endpoint: nonadherence at V4, defined as self-reported nonadherence on the Basel Assessment of Adherence with Immunosuppressive Medication Scale (BAASIS©), investigator-rated nonadherence, and/or V4 tacrolimus trough level outside a predefined range. Secondary endpoints: individual BAASIS items, incidence of rejection, kidney function, and safety. Overall, 153 adult kidney recipients (mean [standard deviation] time post-transplant 5.8 [4.6] years) were included. Nonadherence was high at V4 (67.7% [95% confidence interval 58.9%, 75.6%]). Medication-taking adherence was 86.9% and 91.3% at V1 and V4, respectively; adherence to timing of medication intake was 58.2% and 58.3%, with little evidence of missed doses/drug holidays. Investigators rated adherence “good” in 85.6% of patients (V4). Two (1.3%) patients had acute rejection episodes. Kidney function remained stable (mean creatinine clearance, V1: 62.1 mL/min; V4: 65.3 mL/min). Investigators rated effectiveness of PR-T as “very good”/“good” in 91.5% of patients. Most patients (94.7%) found PR-T dosing more convenient than immediate-release tacrolimus. PR-T was well tolerated with high medication persistence. |
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| Item Description: | Gesehen am 13.09.2019 First published: 20 October 2017 |
| Physical Description: | Online Resource |
| ISSN: | 1399-0012 |
| DOI: | 10.1111/ctr.13142 |